Celator Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track status to CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML). CPX-351 is a liposomal formulation of a synergistic 5:1 molar ratio of cytarabine and daunorubicin.
CPX-351 is currently being evaluated in a multicenter Phase 3 study vs. “7+3” in 300 patients 60–75 years old with untreated high risk (secondary) AML. Results for the primary endpoint of overall survival is expected in the first quarter of 2016.
Previously CPX-351 was granted Orphan Drug status by the FDA for the treatment of AML.
For more information call (609) 243-0123 or visit Celatorpharma.com.